Transcatheter Aortic Valve Implantation With or Without Predilation: A Meta-Analysis

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Technology Evaluation

Background:

• Transcatheter aortic valve implantation (TAVI) is a key treatment for aortic stenosis.
• Systematic predilation using balloon aortic valvuloplasty (BAV) is a debated procedural step.
• Evaluating the necessity and impact of BAV prior to TAVI is crucial for optimizing patient outcomes.

Purpose of the Study:

• To assess the impact of systematic balloon aortic valvuloplasty (BAV) predilation on transcatheter aortic valve implantation (TAVI) outcomes.
• To compare device success and key clinical endpoints between TAVI with and without prior BAV.
• To analyze outcomes based on study design and valve types (balloon-expandable vs. self-expanding).

Main Methods:

• A systematic meta-analysis of randomized controlled trials (RCTs) and adjusted studies was conducted.
• Data from 15 studies involving 16,408 patients (10,364 with BAV, 6,044 direct TAVI) were analyzed.
• Primary endpoint was device success; secondary endpoints included mortality, aortic regurgitation, stroke, pacemaker implantation, and acute kidney injury.

Main Results:

• Systematic BAV prior to TAVI did not significantly improve device success rates in the overall population, nor in self-expanding or balloon-expandable valve subgroups.
• No significant differences in secondary clinical outcomes were observed between the BAV and direct TAVI groups.
• While postdilation rates were similar in observational studies, RCTs showed lower postdilation rates with BAV.

Conclusions:

• Direct TAVI is a feasible and safe approach, demonstrating comparable device success and clinical outcomes to TAVI with predilation.
• The findings suggest that direct TAVI can be considered a primary approach in current TAVI procedures.
• The routine use of systematic BAV predilation may not be necessary, supporting the adoption of direct TAVI strategies.